Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

A 12-weeks Study to Evaluate Sulforaphane in Treatment of Autism Spectrum Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Central South University
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Jian-Jun Ou, Central South University
ClinicalTrials.gov Identifier:
NCT02879110
First received: August 15, 2016
Last updated: August 22, 2016
Last verified: August 2016
  Purpose
In this proposed study, the investigators will evaluate the the efficacy, safety and related mechanism of sulforaphane in treatment of autism spectrum disorder (ASD). The study will recruit 120 ASD patients, then these patients will be randomized to sulforaphane group or placebo group (60 patients per arm) for 12 weeks clinic trial. Clinical efficacy and safety assessment will be done at screen/baseline, 4 week, 8 week and 12 week. The specific aims are to compare sulforaphane versus placebo on: 1) clinical core symptoms; 2) other behavioral problems and adaptive behaviors. Biological samples also will be collected, and stored to research related mechanisms.

Condition Intervention Phase
Autism Spectrum Disorder
Dietary Supplement: Sulforaphane
Other: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 12-weeks, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Related Mechanism of Sulforaphane in Treatment of Autism Spectrum Disorder

Resource links provided by NLM:


Further study details as provided by Central South University:

Primary Outcome Measures:
  • The change of social impairments of children with autism spectrum disorder [ Time Frame: At baseline, 4 week, 8 week and 12 week/endpoint ]
    Social impairments are measured by Social Responsiveness Scale


Secondary Outcome Measures:
  • The change of rigid interests and behaviors of children with autism spectrum disorder [ Time Frame: At baseline, 4 week, 8 week and 12 week/endpoint ]
    Rigid interests and behaviors are measured by Repetitive Behavior Scale - Revised

  • The change of clinical symptoms of children with autism spectrum [ Time Frame: At baseline, 4 week, 8 week and 12 week/endpoint ]
    Clinical symptoms are measured by Aberrant Behavior Checklist

  • The change of other behavioral problems of children with autism spectrum [ Time Frame: At baseline, 4 week, 8 week and 12 week/endpoint ]
    Other behavioral problems are measured by Achenbach's Child Behavior Checklist

  • The change of adaptive behaviors of children with autism spectrum [ Time Frame: At baseline, 4 week, 8 week and 12 week/endpoint ]
    Adaptive behaviors are measured by Adaptive Behavior Assessment System, Second Edition

  • The change of clinical general impression of children with autism spectrum [ Time Frame: At baseline, 4 week, 8 week and 12 week/endpoint ]
    Clinical general impression is measured by Ohio State University Autism Clinical Global Impression

  • The change of heart rate as measured by stopwatch [ Time Frame: At baseline and 12 week/endpoint ]
  • The change of weight as measured by weighing-machine [ Time Frame: At baseline and 12 week/endpoint ]
  • The change of height as measured by Height measurement tools [ Time Frame: At baseline and 12 week/endpoint ]
  • The change of blood routine test as tested by clinical laboratory [ Time Frame: At baseline and 12 week/endpoint ]
  • The change of fasting blood-glucose as tested by clinical laboratory [ Time Frame: At baseline and 12 week/endpoint ]
  • The change of blood lipid as tested by clinical laboratory [ Time Frame: At baseline and 12 week/endpoint ]
  • The change of liver function as tested by clinical laboratory [ Time Frame: At baseline and 12 week/endpoint ]
  • The change of kidney function as tested by clinical laboratory [ Time Frame: At baseline and 12 week/endpoint ]
  • The change of thyroid function as tested by clinical laboratory [ Time Frame: At baseline and 12 week/endpoint ]
  • The change of HBV test as tested by clinical laboratory [ Time Frame: At baseline and 12 week/endpoint ]
  • The change of helicobacter pylori test as tested by clinical laboratory [ Time Frame: At baseline and 12 week/endpoint ]
  • The change of urine routine test as tested by clinical laboratory [ Time Frame: At baseline and 12 week/endpoint ]
  • Number of participants with treatment-related adverse events as assessed by Systematic Assessment for Treatment Emergent Effects [ Time Frame: At 4 week, 8 week and 12 week/endpoint ]

Other Outcome Measures:
  • The change of Oxidative stress indexes as tested by Oxidative stress indexes detection kit [ Time Frame: At baseline and 12 week/endpoint ]
  • The change of Epigenetics indicators as tested by Epigenetics indicators [ Time Frame: At baseline and 12 week/endpoint ]
  • The change of Cytokines & Chemokines as tested by Cytokines & Chemokines detection kit [ Time Frame: At baseline and 12 week/endpoint ]
  • The change of Metabolites as tested by Metabolites detection kit [ Time Frame: At baseline and 12 week/endpoint ]
  • The change of RNA expression as tested by RNA expression detection kit [ Time Frame: At baseline and 12 week/endpoint ]

Estimated Enrollment: 120
Study Start Date: August 2016
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sulforaphane group
The patients will take sulforaphane for 12 weeks.
Dietary Supplement: Sulforaphane
Sulforaphane (SFN) is a compound within the isothiocyanate group of organosulfur compounds. It is obtained from cruciferous vegetables such as broccoli, Brussels sprouts or cabbages.
Other Name: 85313323
Placebo Comparator: Placebo group
The patients will take placebo for 12 weeks.
Other: Placebo
Placebo tablet is composed of starch.
Other Name: Starch tablet

Detailed Description:
In this proposed study, the investigators will evaluate the the efficacy, safety and related mechanism of sulforaphane in treatment of autism spectrum disorder (ASD). The study will recruit 120 ASD patients, then these patients will be randomized to sulforaphane group or placebo group (60 patients per arm) for 12 weeks clinic trial. Clinical efficacy and safety assessment will be done at screen/baseline, 4 week, 8 week and 12 week. The specific aims are to compare sulforaphane versus placebo on: 1) clinical core symptoms; 2) other behavioral problems and adaptive behaviors. The investigators hypothesize that (1) sulforaphane is superior to placebo in the treatment of clinical symptoms in patients with ASD, measured by the Social Responsiveness Scale, Aberrant Behavior Checklist, Repetitive Behavior Scale - Revised and Ohio State University Autism Clinical Global Impression; (2) sulforaphane is superior to placebo in the treatment of other behavioral problems and adaptive behaviors patients with ASD, measured by Achenbach's Child Behavior Checklist and Adaptive Behavior Assessment System, Second Edition; and (3) Biological samples will be collected, and stored so that the hypothesis sulforaphane may alter oxidative stress indexes or inflammatory biomarkers, and influence histone deacetylase inhibitor mechanism or inflammatory mechanism et al that may be significantly correlated with clinical improvement.
  Eligibility

Ages Eligible for Study:   10 Years to 15 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male with aged 10 to 15 years.
  2. Meet DSM-V diagnostic criteria for autism spectrum disorder, and been checked with Autism Diagnostic Interview-Revised (ADI-R) and Autism Diagnostic Observation Schedule (ADOS).

Exclusion Criteria:

  1. With severe physical disease (i.e. congenital heart disease, thyroid disease, diseases with severe abnormality of liver or kidney function, diseases with abnormality vision or hearing et al.)
  2. With severe central nervous system disease (i.e. epilepsy et al).
  3. With other specific genetic syndromes (i.e. Fragile-X syndrome, Down's syndrome et al.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02879110

Contacts
Contact: Jianjun Ou, M.D., Ph. D. 86-18684971485 oujianjun08@163.com
Contact: Jingping Zhao, M.D., Ph. D. 86-13808465728 zhaojingpingcsu@163.com

Locations
China, Guangdong
Sun Yat-Sen University Not yet recruiting
Guangzhou, Guangdong, China, 510000
Contact: Xiaobing Zou, M.D.       zouxb@163.net   
Contact: Biyuan Chen, Master       cchenbiyuan@gmail.com   
China, Hunan
The second Xiangya hospital of central south university Recruiting
Changsha, Hunan, China, 410001
Contact: Jianjun Ou, M.D., Ph.D    86-18694971485    oujianjun08@163.com   
Contact: Yanan Liu, Master    86-18008422158    610122024@qq.com   
Sub-Investigator: Yidong Shen, M.D., Ph.D         
Sub-Investigator: Yamin Li, M.D., Ph.D         
Sub-Investigator: Yanan Liu, Master         
Sub-Investigator: Lijuan Shi, Ph.D         
Sub-Investigator: Xilong Cui, Ph.D         
Sub-Investigator: Li Liu, Master         
Sub-Investigator: Yan Qiu, Master         
Sub-Investigator: Lu Xiao, Master         
Sponsors and Collaborators
Central South University
Stanley Medical Research Institute
Investigators
Study Chair: Jingping Zhao, M.D., Ph. D. Central South University
Study Director: Jianjun Ou, M.D., Ph. D. Central South University
Study Director: Hua Jin, M.D. Department of Psychiatry, University of California, San Diego
Principal Investigator: Fengyu Zhang, Ph.D. Global Clinical and Translational Research Institute
Principal Investigator: Xiaobing Zou, M.D. Sun Yat-sen University
Principal Investigator: Renrong Wu, M.D.,Ph.D Central South University
  More Information

Publications:

Responsible Party: Jian-Jun Ou, Assistant researcher, Central South University
ClinicalTrials.gov Identifier: NCT02879110     History of Changes
Other Study ID Numbers: ASD201512
Study First Received: August 15, 2016
Last Updated: August 22, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Central South University:
Sulforaphane
clinic trial
Autism Spectrum Disorder
Efficacy
Safety
Mechanism

Additional relevant MeSH terms:
Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders
Sulforafan
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 24, 2017